Data Transparency Consultant
5 days ago
MMS is a leading clinical research organization (CRO) that provides data-focused services to the pharmaceutical, biotech, and medical device industries. Our company is recognized for its exceptional culture and industry best employee retention rate, making us a Great Place to Work certified organization.
We pride ourselves on our innovative approach to complex trial data and regulatory submission challenges, with a proven track record of success across four continents. With an industry-leading customer satisfaction rating, we foster a collaborative and inclusive work environment where employees can thrive.
Job Description
The Senior Transparency Specialist will provide operational support in the following areas:
- Clinical Trial Transparency
- Clinical Trial Data Sharing
- Redaction and anonymization of clinical trial documents in accordance with evolving global regulations
Responsibilities:
- Responsible for providing high-quality transparency deliverables in an efficient manner.
- Technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.).
- Facilitates the initiation, progression and completion of the exchange of information for all Transparency workflow steps, with skill and proficiency.
- Performs quality control reviews of document redaction or anonymization to ensure consistency and accuracy.
- Maintain a strong understanding of regulations and guidance's as they pertain to transparency; ensure deliverable timelines are compliant with regulatory timelines.
- Lead projects with minimal management oversight, including complex projects with multiple team members; coordination independently with the client.
- Tailors communication to diverse audience considering experience, background, and expectations.
- Anticipate and understand customer's needs and preferences and can provide solutions to customer's needs; Develops deliverables according to customer specifications.
- Effectively manage/ prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time.
- Capable of leading Transparency process/tools improvements initiatives and may participate in complex companywide process improvement initiatives.
- Facilitates and fosters positive team environment while supporting independent action to achieve team goals.
- Experience with identifying CCI a plus.
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